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One Drug Shortage Leads to a Movement for Change

Beau Castro
One Drug Shortage Leads to a Movement for Change

The individual stories of patients—and their families—are welcome reminders to the pharmaceutical industry about just how meaningful pharmaceutical development, manufacturing, and delivery are every day to those patients and their families.

“Resolving & Avoiding Drug Shortages and the Health Crises They Create,” a complimentary ISPE Pharma Best Practices Webinar Series webinar on 1 September, shared the story of a patient, her family, and the extreme challenges presented for the severely ill when drug shortages occur—and how one parent is fighting to end those shortages for all families. The end of this story is a happy one because it saw the birth of a nonprofit that is devoted to assisting pediatric oncology patients in securing drugs when a shortage occurs.

Drug shortages are a reality for the pharmaceutical industry, and ISPE has taken major steps to identify the reasons and work on solutions. Input and involvement from organizations all along the supply chain are necessary to be able to minimize and resolve these shortages whenever they occur. Melissa Figgins, Principal, Coal Creek Consulting, LLC, noted that the ISPE Drug Shortages Initiative is making a difference. She cited the article “Engage with Health Authorities to Mitigate and Prevent Drug Shortages” from Pharmaceutical Engineering’s July-August issue and ISPE’s partnership with Pew Charitable Trust to conduct research into market forces and other factors affecting potential and actual shortages as just some ways ISPE is addressing drug shortages. “We must stay engaged as an industry to protect patients,” she said, adding that “joining us today [at the webinar] helps us with that mission.”

Quest for Change

Critical and life-threatening illnesses that require almost split-second administration of pharmaceuticals present a challenge that can literally become a matter of life or death. The webinar highlighted one story of potentially negative impact on a pediatric cancer patient who experienced not one but three shortages of critically needed drugs being administered in a protocol treatment.

Melissa introduced Laura Bray, Chief Change Maker, Angels for Change whose daughter Abby has been battling pediatric cancer. In response to launching the search to locate those missing drugs so that her daughter could continue with the treatment protocol, Laura founded the nonprofit Angels for Change to help others affected by drug shortages, and to develop proactive, systemic changes to bridge gaps in supply and delivery systems.

Laura described the impact of her middle daughter, Abby’s, diagnosis at age 9 with acute lymphoblastic leukemia (ALL) at the end of 2018. “Our lives changed really quickly,” she said, starting the immediate hospital treatment. “Childhood cancer is a family diagnosis,” she said, noting that family life goes on but with disruptions and with more and new decisions to navigate. There are also small changes and questions, including small ones like “can I still see my friends?” and big ones like “will people laugh at me when my hair falls out?” During this time, Laura began calling herself “caretaker in chief and chief normalcy officer.”

Laura and her family received assurances from the doctors that a cocktail of drugs given within set time frames were the road to successful treatment of ALL. The first months of treatment involved figuring out how to follow through all of the protocols for the drugs; doctors warned that compliance to the protocol is key for success in treatment. These assurances made it somewhat easier to try to allay the fears of a nine-year-old.

The commitment to following a protocol so difficult that it included, for instance, 25 pills consumed in one 30-minute time frame helped Laura, the nurses and the doctors to encourage Abby through the start of treatment, and through dealing with pain, a port, and losing her hair. “It is all for the protocol, the medicine, the timing. We talk about it all the time.”

Then the first drug shortage happened in April 2019. “I did not know these existed and was blindsided by that knowledge,” Laura said. When Abby asked if she was going to die because she could not get her medicine, “I gave my daughter the only answer I could: I said, ‘I’m going to try to get it for you.’ That’s what I did!”

While Laura had determination, she had no experience or any idea how to approach a drug shortage. She put her skill as a business professor to use, including her knowledge of supply chains and economics. “I’m just an ordinary person but just being willing to try, especially when you are outside your comfort zone, extraordinary things can happen.”

She started calling 800 numbers asking if anyone would help. She learned that there were two manufacturers of the drug; a lab that created it and a distributor who licensed and shipped it. While she contacted organizations throughout the supply chain, it was McKesson, the shipper, that responded in a way that helped. “They were the only ones who were really answering questions and talking about it like it is a real problem,” Laura said. Many others simply said the drug supply would pause and then resume—which did not help in the need for the specific drug at a specific point in Abby’s treatment protocol. McKesson offered to help and the team in charge of the drug found that while they did not have the drug in stock, it had been shipped and was in the market—and promised Laura that if she could locate it, they would deliver it to the hospital treating Abby.

Laura enlisted friends and neighbors to assist with a calling campaign to hospitals to locate the drug. It was found at a hospital where no patient was on the protocol. McKesson made good on its promise and got the drug to the hospital that was treating Abby.

“After that, I couldn’t stop thinking about what had happened and the shortage—it was still ongoing,” Laura said. “What about every other child?”

So she researched deeper into drug shortages, “but answers created more questions.” She learned that shortages were not new and that many people had been working for decades on the problem. “I came to realize this was not a one-off but a real, systemic problem. The market was not functioning like free market is supposed to—and the customer is so far removed it can be completely hidden.”

Laura believed that “no one should have to hear ‘we don’t have the medicine to save your life.’” She decided that she would try to help stop the problem and ask experts if they would try with her. She got a meeting with the FDA Drug Shortage Task Force, and after that, founded Angels for Change. After the launch, the second drug shortage for Abby’s treatment occurred and once again, Abby was on hold with her protocol.

This time, Laura had met many experts who were able to help her, which also helped when the third shortage occurred. Each of the three drug shortages was for different reasons and were resolved in different ways, Laura noted; each required more problem solving and meeting with more “change makers” to help with resolution. Her relationship grew with McKesson, which maintained their promise to distribute for other patients when the drug was found.

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Patients First

Jody Garey, PharmD, Director, Oncology Analytics, McKesson was one of the team who helped Laura initially and continues to help Angels for Change and works to alleviate drug shortages. She explained that the first drug shortage impacting Abby was for a branded, single-source compound, complex to make, with no clinical alternatives and used in curative therapy for a small patient population . When Laura contacted McKesson, it had no process to address the situation.

She explained that the McKesson team fell back on a core value: “it is not just a package, it is a patient.” They tried to think of what to do now to help this parent of a patient. Since McKesson could not locate the drug themselves, they made a commitment as an organization that if Laura could locate it at a hospital or clinic and it was not earmarked for another patient, McKesson would get the drug and get it to Abby so she could continue her treatment.

Although this drug shortage was a fairly unique situation, Jody said that drug shortages tend to be more common in generics and McKesson’s team has several strategies to address these:

  1. Multisourcing (using multiple manufacturers). They use clinical pharmacists to help identify the most critical oncology agents without alternatives and that are curative.
  2. Communicate and collaborate with manufacturing partners.
  3. Use of data and analytics. Real-world data is critical to history and future, Jody said. Several programs are used to manage existing supplies so a “fair share” program using historical sales volume assesses if a shortage is feared. “That allows us to be flexible, patient-focused, and manage existing supply among the patients as they come into clinic, so existing supply can be spread out to accommodate patient needs,” Jody explained. Fair share has been used to manage drugs during the covid-19 pandemic.

Melissa noted that the ISPE Drug Shortage Prevention Tool offers a similar process.

Jody talked about how McKesson is developing new approaches to drug shortages, spurred on by Laura’s reach out and the work being done by Angels for Change. The team working with the first shortage drug put together a cross-functional group to replicate Laura’s actions: locate the drug, find out if it was earmarked for another patient, return the product, and get it to the patient in need.

Laura noted that this process has resulted in a much shorter time frame for delivery to patients. While it took 10 days for Abby’s first drug shortage to be resolved, now it takes just two or three days for McKesson to resolve a shortage.

“This timing is so critical not just for curative purposes but also because timing is about how the drugs work together and react together,” Laura said. “We have a patient we advocated for and McKesson helped resolve the shortage through the process. With just a two-week delay, since it took the parent a while to find us, just that difference—the patient is back on protocol but because of how the drugs work together, now that patient has (chemo induced) diabetes. This was on top of cancer treatment and it wasn’t necessary!”

She emphasized the importance of multiple participants in the supply chain. “It is not just enough to have relationships with drug distributors. We must look at all the different players through the chain and recognize that there is a chain of custody of product and limited visibility by design.” Surmounting this limited visibility to locate and deliver the needed drugs is a goal.

In addition to the supply chain, there is a need to look at distribution and redistribution solutions. While proactive processes in the supply and distribution chain are helping, they do not eliminate the problem of drug shortages, Laura said.

Reactive processes like Laura’s approach to solve the shortages affecting Abby can help—but more is needed: systemic processes to make sure chain of custody and limited visibility by design do not create barriers to obtaining drugs.

Angels for Change continues individual patient advocacy while seeking more partners like McKesson to assist in addressing the systemic challenges. A major step in this direction is Summit One on 30 October, a conference to look at pediatric oncology as the pilot for broader systemic solutions. McKesson is one of the sponsors, and speakers will include one from the FDA.

She urged webinar attendees to help. “Will you try? Will you be a change maker with us?”

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